esophageal squamous cell carcinoma
Conditions
Interventions
arm 2:Adebrelimab + Recatisibiumab (150 mg) + Albumin-bound paclitaxel + carboplatin
arm 1:Adebrelimab + Recatisibiumab (300 mg) + Albumin-bound paclitaxel + carboplatin
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed esophageal squamous cell carcinoma; 2. Thoracic esophageal cancer with clinical stage cT1b–cT2N+ or cT3–cT4a any N, as assessed by CT/PET-CT (according to the 8th edition of the AJCC); 3. Age 18–75 years, regardless of gender; 4. ECOG Performance Status (PS) 0–1; 5. Measurable tumor lesions or evaluable non-measurable lesions; 6. No prior anti-tumor treatment for esophageal cancer, including radiotherapy, chemotherapy, or surgery; 7. Planned to undergo surgical resection after neoadjuvant therapy; 8. Normal or mild-to-moderate pulmonary function abnormalities (VC% > 60%, FEV1 > 1.2L, FEV1% > 40%, DLco > 40%), suitable for esophagectomy; 9. No contraindications to surgery; 10. Adequate function of major organs (excluding transfusion of blood products or use of hematopoietic growth factors within 14 days): - Normal bone marrow reserve function: white blood cell (WBC) count >= 3.0×10^9/L; absolute neutrophil count (NEUT) >= 1.5×10^9/L; platelet count (PLT) >= 100×10^9/L; hemoglobin (Hb) >= 90 g/L. - Normal renal function: serum creatinine (SCr) = 60 ml/min (Cockcroft-Gault formula). - Normal liver function: total bilirubin (TBIL) <= 1.5×ULN; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels <= 2.5×ULN. - Normal coagulation function: international normalized ratio (INR) <= 1.5×ULN; activated partial thromboplastin time (APTT) <= 1.5×ULN. 11. Patients with reproductive potential must use a medically accepted method of contraception (e.g., intrauterine device, oral contraceptives, or condoms) during the study treatment period and for 6 months after the end of the study treatment; serum HCG or urine HCG test must be negative within 72 hours before enrollment; and must not be breastfeeding; 12. Patients voluntarily agree to participate in this clinical study, provide written informed consent, have good compliance, and are willing to cooperate with follow-up visits; 13. Measurable tumor lesions or non-measurable lesions that can be assessed.
Exclusion criteria
Exclusion criteria: 1. Poor nutritional status with BMI 10 mg/day prednisone or equivalent); inhaled or topical corticosteroids and adrenal corticosteroid replacement with > 10 mg/day prednisone or equivalent are permitted in the absence of active autoimmune disease; c) Receipt of a live-attenuated vaccine within 4 weeks before the first administration of the study drug; d) Major surgery or severe trauma within 4 weeks before the first administration of the study drug; 4. Presence of any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (thyroid hormone replacement therapy is allowed); patients with psoriasis or childhood asthma/allergy that has completely resolved without intervention in adulthood may be considered, but those requiring medical intervention with bronchodilators are excluded; 5. History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation; 6. Presence of uncontrolled cardiac clinical symptoms or diseases, including but not limited to: (1) NYHA Class II or higher heart failure, (2) unstable angina, (3) myocardial infarction within the past year, (4) clinically significant supraventricular or ventricular arrhythmias that are not controlled or poorly controlled with clinical intervention; 7. Severe infection (CTCAE Grade 2) within 4 weeks before the first administration of the study drug, such as severe pneumonia, bacteremia, or infection with complications requiring hospitalization; baseline chest imaging showing active pulmonary inflammation, presence of signs or symptoms of infection within 14 days before the first administration of the study drug, or need for oral or intravenous antibiotic therapy, excluding prophylactic use of antibiotics; 8. Active tuberculosis infection identified by history or CT scan, or history of active tuberculosis infection within the past year, or history of active tuberculosis infection more than 1 year ago without proper treatment; 9. Active hepatitis B with HBV DNA >= 2000 IU/mL or 10^4 copies/mL, or hepatitis C (positive HCV antibody and HCV RNA above the lower limit of detection). 10. Diagnosis of other malignancies within 5 years before the first administration of the study drug, unless the malignancy has a low risk of metastasis or death (5-year survival rate > 90%), such as adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or cervical carcinoma in situ, which may be considered for enrollment; 11. Pregnant or breastfeeding women; 12. Presence of other factors that may lead to forced discontinuation of the study, as judged by the investigator, such as
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| R0 Removal rate;major pathologic response;Disease-Free Survival;Overall Survival ;Objective Response Rate; | — |
Countries
China
Contacts
Public ContactWu Chao
Chinese PLA General Hospital
Outcome results
None listed